EP0646353A1 - Multi-branched ostheosynthesis staple having a dynamic autoretentive compression - Google Patents
Multi-branched ostheosynthesis staple having a dynamic autoretentive compression Download PDFInfo
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- EP0646353A1 EP0646353A1 EP94420247A EP94420247A EP0646353A1 EP 0646353 A1 EP0646353 A1 EP 0646353A1 EP 94420247 A EP94420247 A EP 94420247A EP 94420247 A EP94420247 A EP 94420247A EP 0646353 A1 EP0646353 A1 EP 0646353A1
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- wire
- temperature
- branches
- lateral branches
- connection portion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
Definitions
- the invention relates to a new type of multi-branch osteosynthesis clip having characteristics of dynamic compression, self-retention and mechanical stability.
- dynamic compression is meant the ability of certain staples to generate a resulting compressive force between the points at which they are implanted and, more particularly on either side of a bone fracture center.
- Surgical staples used for reduction of fractures and fixation of bones and soft tissues must have several essential characteristics. First, they must develop a constant compression effect over time. They must be well anchored so as to avoid their detachment after implantation, detachment generally inherent in the movements of the joint or simply of the bone on which they are implanted. In addition, the stability of the fracture zone through good immobilization is an important condition for achieving bone consolidation. Finally, the method of implantation or removal of staples must be simple, easy to implement, and generating a minimum of bone trauma.
- said staples are made of a martensitic material, for example an alloy of the nickel / titanium or titanium / niobium type, and to which a phenomenon known as of shape memory, capable of bringing their ends closer together when the clip is at a temperature higher than the austenitic transformation temperature of said material that composes it.
- This shape memory phenomenon is due to the reversible thermo-elastic martensitic transformation.
- This phenomenon which is now well known, consists in giving a material a defined form which is treated at a temperature above the austenitic transformation temperature A s of the material, then in giving it another form also defined at a lower temperature.
- the martensitic temperature is lower than the austenitic temperature.
- an osteosynthesis clip made of a martensitic material in which, the transition from temperature from martensitic temperature to austenitic temperature, induces a shortening of the length of the base of the clip, at least partially, and, as a corollary, the approximation of the ends of said branches constituting the clip.
- this type of clip of a constant dynamic compression over time and homogeneous, it also allows compression both at the surface part of the bone and in its deep part, taking into account the fact that the extremities branches which constitute it are also educated to get closer to each other.
- this type of staple is of delicate construction, given its particular shape, in particular the provision at its base of a portion of reduced section and therefore generating an education difficult to induce.
- the object of the invention is to provide a multi-branch osteosynthesis clip of the type in question allowing, in a single operation, to ensure, by its shape and its ability to adapt to the shape of the bone to be repaired, the mechanical stability of two or more elements of the bone in the fracture zone.
- This osteosynthesis clip made of a thermo-elastic martensitic alloy, the martensitic transformation temperatures M s and austenitic A s can vary, depending on the applications, between 20 ° C to 70 ° C, has lateral branches intended to be inserted on either side of the focal point of a bone fracture to be repaired, said branches being connected together by at least one connection portion, the branches and the connection portion being educated so as to curl substantially towards the center respectively of the clip and to shorten under the effect of the temperature, when the latter exceeds the austenitic transformation temperature A s of the material of which it is composed.
- It is characterized in that it consists of a unitary and monobloc wire, with which at least one of the branches which constitute it is produced by at least partial folding of said wire on itself.
- the two free ends of the wire can each constitute another branch, said branches being intended to be inserted into or in contact with the bone at one of the edges of the fracture.
- connection portion of the clip educated so as to shorten under the effect of temperature, adopting an at least partially curved shape when passing to a temperature above the austenitic transformation temperature of the material martensitic which constitutes it, is also constituted by the partial folding of the wire constituting the staple, in the extension of the lateral branch (es) thus formed.
- the lateral branch or branches formed by partial folding of the constituent wire on itself are capable of adopting a curved shape under the effect of the temperature. In this way, the self-retaining capabilities of the clip are improved.
- connection portion of the clip under the effect of temperature is obtained by partial flap in the direction of the middle of said clip of the elements of the portion constituted by the wire alone and not by partial folding of the latter on itself.
- connection portion of the clip under the effect of temperature is obtained under the combined effect of the adoption of a curved shape in the area of said portion formed by partial folding of the constituent wire, and by the flap towards the middle of the staple of the elements of the portion constituted by the wire alone.
- the Y-shaped clip has three branches, one of which is formed by partial folding of the wire constituting the clip on itself, the other two branches being capable of approach or move away from each other when passing at a temperature higher than the austenitic transformation temperature of the material.
- the clip also has three branches, these are distributed so as to give the clip a T-shape, namely a main branch formed by partial folding and the other two branches located at the end of the upper bar of the T being constituted by the two free ends.
- the clip also has three branches, these are distributed so as to give the clip a V-shape, in which one of the branches is formed by partial folding over it- even of the constituent wire of the staple, and in which the two other branches are likely to approach or move away from one another when passing at a temperature higher than the austenitic transformation temperature of the material.
- each of the branches is constituted by partial folding of the constituent wire of the clip on itself.
- the clip has four branches, distributed so as to give the clip a double Y shape, the central bar being common to the two Y, the two branches of one of them being formed by partial folding in on itself of the wire, and the two branches of the other being constituted by the two free ends of said wire, the two branches of each of the two sets also being capable of approaching or deviating, according to the education in shape memory which is given to them, at the time of the passage from the temperature to a temperature higher than the austenitic transformation temperature of the material.
- the clip has a double-T shape, connected to each other by their main bar, two of the branches being produced by partial folding of the wire on itself, both others being constituted by the two free ends of said wire.
- the clip has a stool shape, each of the branches of said stool being constituted by the partial folding of the wire on itself, the two free ends of the wire coming to meet at one of the branches.
- the different connecting portions of the branches between them adopt a wavy shape when the temperature passes to a temperature higher than the austenitic transformation temperature of the material, or only two opposite connecting portions undergo such a shortening.
- Figures 1 and 2a, 2b and 2c show a first embodiment of the invention with three Y-shaped branches, respectively at a temperature below the martensitic transformation temperature and above the austenitic transformation temperature of the material which compound.
- Figures 3 and 4a, 4b are schematic representations of the Y-shaped clip of Figures 1 and 2 in place at a bone fracture area.
- Figures 5 and 6 are representations similar to Figures 1 and 2, of a staple with three T-shaped branches.
- Figure 7 is a schematic representation of the implementation of the clip of Figures 5 and 6 at a bone fracture focus.
- Figures 8 and 9a, 9b and 9c are representations similar to Figures 1 and 2, of a staple with four branches in the form of double Y.
- Figures 10 and 11 are representations similar to Figures 1 and 2, of a staple with four branches in the form of double T.
- Figures 12 and 13 are figures similar to those of Figures 10 and 11 of a clip also in the form of a double T, according to another embodiment of the invention.
- Figure 14 is a schematic representation of the placement of the clip of Figures 12 and 13 at a bone fracture focus.
- Figures 15 and 16 are representations similar to Figures 1 and 2, of a staple with three V-shaped branches.
- Figures 17 and 18 are schematic representations similar to those of Figures 1 and 2 of a staple with three branches in the form of a stool.
- FIGS. 19, 20 and 21 are schematic representations similar to FIGS. 1 and 2 of a staple with four branches in the form of a stool, FIG. 21 being a variant of FIG. 20.
- the osteosynthesis clips according to the invention are made of a martensitic material that meets the required bio-compatibility properties.
- this martensitic material consists of a nickel / titanium alloy or an alloy based on copper, aluminum or zinc.
- the osteosynthesis clip (1) basically comprises lateral branches (2, 3, 4), interconnected by a base or connection portion (5, 6, 7, 8), the set of these various elements being constituted by means of a single monobloc wire of circular or polygonal section (square, rectangular), etc., produced in said alloy.
- the lateral branches (2, 3 and 4) described in more detail below are rectilinear and directed appreciably perpendicularly to the connection portion.
- the clip has three lateral branches (2, 3 and 4) and the connection portion forms a Y, the base (7, 8) of which is made up by partial folding of the wire constituting the clip on itself, and which continues with two divergent branches (5, 6), formed by the wire in a unitary manner, and the two free ends of which form two lateral branches (3 , 4).
- the clip is thus made up of a single monobloc wire, folded back on itself, the extreme branch (2) being constituted by the partial folding of the wire back on itself, and continuing at the base of the Y.
- the wire is educated so that when the temperature is lower than the martensitic temperature M s of the material of which it is composed, the lateral branches (2, 3, 4) are rectilinear, as well as the elements (5, 6, 7, 8) constituting the connection portion of said Y and, when the temperature is higher than the austenitic transformation temperature A s of said material, the lateral branches adopt a curved position directed towards the inside of the clip, as shown in FIG. 2a, and in addition, the connection portion (7,8) also adopts a corrugated or curved profile, for example located in the plane of said portion, so as to obtain a shortening of the initial length L of said clip according to a new value L '(L' ⁇ L) (see FIG. 2a).
- This shape memory can be acquired by the various elements, namely the lateral branches (2, 3, 4) and the connection portion (7, 8) by giving them a particular shape at a temperature higher than the austenitic transformation temperature. A s of the material that composes them, then giving them another shape and in particular a rectilinear shape at a temperature below the martensitic transformation temperature M s of said material.
- a rectilinear shape memory is acquired respectively for the connection portion and for the lateral branches at a temperature below the martensitic transformation temperature and a wavy or curved shape memory for the portion connection (7, 8), with the lateral branches (2, 3, 4) adopting a curved shape for a temperature above the austenitic threshold, are obtained.
- the spacing l between the two upper branches (5, 6) constituting the Y of the connection portion, and therefore between the lateral branches (2, 3), can be either reduced or increased when the temperature exceeds the austenitic threshold A s of the material, and this as a function of the desired effect.
- this clip is carried out as follows. Said clip is brought to a temperature below the martensitic transformation temperature M s of the material of which it is composed, the connection portion (7,8) and the lateral branches being in fact rectilinear, the latter being even substantially perpendicular to said portion. .
- the clip is then implanted on either side of the focal point of the fracture, and this by compaction, pre-orifices having advantageously been made beforehand by the surgeon.
- the temperature is above the austenitic threshold, the clip deforms and adopts a shape defined by its shape memory. In this way, there is a double compression effect, respectively at the level of the cortical bone and the cancellous bone, as well as a self-retention effect, inherent in the bending of the lateral branches (2, 3 , 4).
- FIGS. 3 and 4 show the clip in place at the focal point of a bone fracture, of which the broken zone has been shown by a broken line.
- a first method of positioning (FIGS. 3 and 4a) only one of the cortical walls of the bone is pierced to allow the positioning of the staple.
- FIG. 4b the two opposite cortical walls of the bone are pierced, so as to allow the lateral branches (2, 3, 4) to pass right through. the bone, and therefore, ensure better compression of the two elements of the bone in contact with each other, and increased stability.
- the shortening of the connection portion is obtained by flap of the upper branches (5, 6) of said portion in the direction of the lateral branch (2), also obtained by shape memory at a temperature above the austenitic threshold.
- the shortening of the connection portion is obtained by a combination of the two preceding effects, namely, both by the adoption by the base (7, 8) of said portion of a curved profile, and by folding or flap towards the lateral branch (2) of the upper branches (5, 6) of this portion.
- the clip always has three lateral branches (2, 3, 4), but the connection portion between these branches has a T-shape.
- one of the branches (2) is formed by the partial folding in on itself of the wire which constitutes it, and the connection portion (7, 8) is likely to be shortened by adopting a corrugated profile or curve when the temperature goes above the austenitic threshold.
- the two upper branches (5, 6) constituting the connection portion, and hence the two lateral branches (3, 4) which extend them are advantageously educated to approach one of the 'other, as materialized by the two arrows in Figure 6.
- the two side branches (3, 4) bend in the direction of one another at such a temperature.
- such a clip is adapted to ensure on the one hand, compression at a focal point of bone fracture, but also a second compression effect, at the level of a cracked area (14) contiguous to the fracture proper, and this by ensuring an effective tightening inherent in the bringing together of the two upper branches (5, 6) of the connecting portion.
- the clip has four side branches (2, 3, 4, 9) in a general shape of two Y end to end. Two of the side branches (2, 9) are formed by partial folding of the wire on itself, and the other two are formed by the two free ends of said wire.
- the connection portion is made up on the one hand, by the extension of the lateral branches (2, 9), and therefore by partial folding back on itself of the wire constituting the staple, and on the other hand, by the branches upper (5, 6) diverging from the central area of the clip, and whose free ends constitute the two lateral branches (3, 4).
- the "double" connection portion (7, 8) is liable to undergo deformation by shape memory according to a double undulation or curvature, advantageously in the plane of said portion, materializing by a shortening of the 'clip (1).
- this shortening can also be obtained by flap or partial folding of the upper branches (5, 6) of the connection portion in the direction of the lateral branches (2, 9) (see FIG. 9b), or by combination of the two effects. previous (see Figure 9c).
- the two lateral branches, respectively (3, 4) and (2, 9) constituting the two sets of branches of the double Y, are liable to deviate or, on the contrary, to approach one another during the passage of the temperature above the austenitic transformation threshold of the material, or even one of the clearances deviate and the other approximate depending on the desired effect.
- This effect is obtained by education, like the effects previously described.
- the clip has four lateral branches (2, 3, 4, 9), connected together by a double T-shaped connecting portion, comprising respectively two lateral branches ( 2, 9) produced by partial folding in on itself of the wire constituting the staple, and two lateral branches (3, 4) constituted by the two free ends of said wire.
- a temperature higher than the austenitic transformation temperature A s of the material we observe in FIG. 11, the adoption by the "double" connection portion (7, 8) of a wavy or curved profile, suitable for induce a reduction in the distance separating the two sets of two lateral branches, and thereby ensuring dynamic compression at fracture level.
- said side branches of each of the two sets, respectively (2, 9) and (3, 4) are educated so that at such a temperature, they bend in the direction of the set of opposite side branches.
- the lateral branches (2, 3, 4, 9) are educated to be in a slightly bent form at a temperature below the martensitic transformation temperature M s of the material, and to adopt a much more curved shape (FIG. 13) at a temperature above the austenitic threshold.
- This bending takes place substantially in the plane integrating the two respective sets (2, 9) and (3, 4) of lateral branches.
- This embodiment of the invention proves to be of advantageous application for the reduction of fractures or fractures of small bones. Indeed, and as schematically shown in FIG.
- the lateral branches no longer penetrate into the bone, but surround it, and provide a tightening and a dynamic compression capable of allowing its "repair", the dimensions of the clip, and in particular the degree of bending of the lateral branches being chosen so as to ensure the desired degree of tightening.
- connection portion is in the form of a V.
- said portion (7, 8) is educated to shorten by adopting a curved or wavy profile as soon as the temperature exceeds the austenitic threshold, and each of the lateral branches (2, 3, 4) bends towards the center of the clip at such a temperature .
- the clip also has three lateral branches (2, 3, 4), but in a stool shape.
- the three branches are then each formed by partial folding in on itself of the wire constituting the staple, and are educated to curl in the direction of the center of the staple at a temperature above the austenitic threshold of the material.
- the connecting portions between said branches are educated to adopt a curved profile, so as to reduce the distance separating said lateral branches.
- this type of staple is applicable for the reduction of multiple bone fractures, of the metacarpal type.
- each of the branches is constituted by a partial folding of the wire, the two free ends of the wire joining, for example at one of the branches.
- the different connecting portions (10 - 13) undergo a change in shape according to a wavy or curved shape, inducing a shortening of each of the diagonals constituting the base of the stool.
- connection portions for example (11, 12) are educated so as to have a wavy shape, and therefore a shortening of the distance separating the two pairs of lateral branches (2, 4) and (3, 9) when the temperature passes above the austenitic threshold, depending on the choice of the surgeon.
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Abstract
Description
L'invention concerne un nouveau type d'agrafe d'ostéosynthèse multi-branches présentant des caractéristiques de compression dynamique, d'auto-rétention et de stabilité mécanique.The invention relates to a new type of multi-branch osteosynthesis clip having characteristics of dynamic compression, self-retention and mechanical stability.
Par "compression dynamique", on entend la faculté que présentent certaines agrafes de générer une force de compression résultante entre les points au niveau desquels elles sont implantées et, plus particulièrement de part et d'autre d'un foyer de fracture osseux.By "dynamic compression" is meant the ability of certain staples to generate a resulting compressive force between the points at which they are implanted and, more particularly on either side of a bone fracture center.
Les agrafes chirurgicales utilisées pour la réduction des fractures et la fixation des os et des tissus mous, doivent posséder plusieurs caractéristiques essentielles. Tout d'abord, elles doivent développer un effet de compression constant dans le temps. Elles doivent être bien ancrées de telle sorte à éviter leur décrochement après implantation, décrochement généralement inhérent aux mouvements de l'articulation ou simplement de l'os sur lequel elles sont implantées. En outre, la stabilité de la zone de fracture par une bonne immobilisation constitue une condition importante pour aboutir à une consolidation osseuse. Enfin, le mode d'implantation ou d'enlèvement des agrafes doit être simple, facile à mettre en oeuvre, et générant un minimum de traumatismes osseux.Surgical staples used for reduction of fractures and fixation of bones and soft tissues must have several essential characteristics. First, they must develop a constant compression effect over time. They must be well anchored so as to avoid their detachment after implantation, detachment generally inherent in the movements of the joint or simply of the bone on which they are implanted. In addition, the stability of the fracture zone through good immobilization is an important condition for achieving bone consolidation. Finally, the method of implantation or removal of staples must be simple, easy to implement, and generating a minimum of bone trauma.
Parmi les différents types d'agrafes connus à ce jour, il en est un dans lequel lesdites agrafes sont réalisées en un matériau martensitique, par exemple en un alliage du type nickel/titane ou titane/niobium, et auxquelles on confère un phénomène dit de mémoire de forme, susceptible d'induire un rapprochement de leurs extrémités lorsque l'agrafe se situe à une température supérieure à la température de transformation austénitique dudit matériau qui la compose. Ce phénomène de mémoire de forme est du à la transformation martensitique thermo-élastique reversible. Ce phénomène aujourd'hui bien connu, consiste à donner à un matériau une forme définie que l'on traite à une température supérieure à la température de transformation austénitique As du matériau, puis à lui donner une autre forme également définie à une température inférieure à la température martensitique Ms dudit matériau, et à répéter un certain nombre de fois cette opération, en fonction de la nature de l'alliage utilisé, afin de donner à ce matériau sa mémoire de forme définitive. La température martensitique est inférieure à la température austénitique.Among the different types of staples known to date, there is one in which said staples are made of a martensitic material, for example an alloy of the nickel / titanium or titanium / niobium type, and to which a phenomenon known as of shape memory, capable of bringing their ends closer together when the clip is at a temperature higher than the austenitic transformation temperature of said material that composes it. This shape memory phenomenon is due to the reversible thermo-elastic martensitic transformation. This phenomenon, which is now well known, consists in giving a material a defined form which is treated at a temperature above the austenitic transformation temperature A s of the material, then in giving it another form also defined at a lower temperature. at the martensitic temperature M s of said material, and repeating this operation a certain number of times, depending on the nature of the alloy used, in order to give this material its final shape memory. The martensitic temperature is lower than the austenitic temperature.
Si certes ces agrafes permettent de générer une compression dynamique au niveau de l'extrémité de leurs branches, celle-ci s'avère généralement insuffisante pour la totalité de la fracture au niveau de laquelle elles sont implantées et même parfois rédhibitoire, car cette compression est disymétrique. En effet, elle a tendance à rapprocher la partie profonde de la zone de la fracture et à écarter la partie superficielle de cette même zone.While these staples can generate dynamic compression at the end of their branches, it is generally insufficient for the entire fracture at which they are implanted and even sometimes unacceptable, because this compression is asymmetrical. In fact, it tends to bring the deep part of the fracture zone closer and to spread the superficial part of this same zone.
Afin de pallier ces inconvénients, on a proposé dans le document EP-A-0 488 906 du Demandeur, une agrafe d'ostéosynthèse réalisée en un matériau martensitique dans lequel, le passage de la température de la température martensitique à la température austénitique, induit un raccourcissement de la longueur de la base de l'agrafe, au moins partiellement, et, corolairement, le rapprochement des extrémités desdites branches constitutives de l'agrafe. Outre la génèse par ce type d'agrafe d'une compression dynamique constante dans le temps et homogène, elle permet également une compression tant au niveau de la partie superficielle de l'os que dans sa partie profonde, compte tenu du fait que les extrémités des branches qui la constituent sont également éduquées pour se rapprocher l'une de l'autre.In order to overcome these drawbacks, there has been proposed in document EP-A-0 488 906 by the Applicant, an osteosynthesis clip made of a martensitic material in which, the transition from temperature from martensitic temperature to austenitic temperature, induces a shortening of the length of the base of the clip, at least partially, and, as a corollary, the approximation of the ends of said branches constituting the clip. In addition to the genesis by this type of clip of a constant dynamic compression over time and homogeneous, it also allows compression both at the surface part of the bone and in its deep part, taking into account the fact that the extremities branches which constitute it are also educated to get closer to each other.
Cependant, toutes les agrafes à deux branches ne confèrent pas une stabilité mécanique au foyer de la fracture osseuse. De fait, il est souvent nécessaire de positionner plusieurs agrafes pour aboutir à cette stabilité, induisant plusieurs opérations consécutives, conduisant en outre à une stabilité imparfaite.However, not all two-legged staples provide mechanical stability to the focus of the bone fracture. In fact, it is often necessary to position several staples to achieve this stability, inducing several consecutive operations, also leading to imperfect stability.
Par ailleurs, ce type d'agrafe est de réalisation délicate, compte tenu de sa forme particulière, notamment du ménagement au niveau de sa base d'une portion de section réduite et donc générant une éducation difficile à induire.Furthermore, this type of staple is of delicate construction, given its particular shape, in particular the provision at its base of a portion of reduced section and therefore generating an education difficult to induce.
L'objet de l'invention est de proposer une agrafe d'ostéosynthèse multi-branches du type en question permettant en une seule opération d'assurer par sa forme et sa capacité d'adaptation à la forme de l'os à réparer, la stabilité mécanique des deux ou plusieurs éléments de l'os de la zone de fracture.The object of the invention is to provide a multi-branch osteosynthesis clip of the type in question allowing, in a single operation, to ensure, by its shape and its ability to adapt to the shape of the bone to be repaired, the mechanical stability of two or more elements of the bone in the fracture zone.
Cette agrafe d'ostéosynthèse réalisée en un alliage martensitique thermo-élastique, dont les températures de transformation martensitique Ms et austénitique As peuvent varier, en fonction des applications, entre 20 ° C à 70 ° C, comporte des branches latérales destinées à être insérées de part et d'autre du foyer de la fracture d'un os à réparer, lesdites branches étant raccordées entre elles par au moins une portion de raccordement, les branches et la portion de raccordement étant éduquées pour respectivement se recourber sensiblement vers le centre de l'agrafe et pour se raccourcir sous l'effet de la température, lorsque celle-ci dépasse la température de transformation austénitique As du matériau qui la compose.This osteosynthesis clip made of a thermo-elastic martensitic alloy, the martensitic transformation temperatures M s and austenitic A s can vary, depending on the applications, between 20 ° C to 70 ° C, has lateral branches intended to be inserted on either side of the focal point of a bone fracture to be repaired, said branches being connected together by at least one connection portion, the branches and the connection portion being educated so as to curl substantially towards the center respectively of the clip and to shorten under the effect of the temperature, when the latter exceeds the austenitic transformation temperature A s of the material of which it is composed.
Elle se caractérise en ce qu'elle est constituée d'un fil unitaire et monobloc, avec lequel au moins l'une des branches qui la constituent est réalisée par repliage au moins partiel dudit fil sur lui-même. Les deux extrémités libres du fil peuvent constituer chacune une autre branche, lesdites branches étant destinées à venir s'insérer dans ou au contact de l'os au niveau de l'un des bords de la fracture.It is characterized in that it consists of a unitary and monobloc wire, with which at least one of the branches which constitute it is produced by at least partial folding of said wire on itself. The two free ends of the wire can each constitute another branch, said branches being intended to be inserted into or in contact with the bone at one of the edges of the fracture.
Selon l'invention, il est possible d'obtenir un certain nombre de branches supplémentaires constituées par le repliage partiel du fil sur lui-même.According to the invention, it is possible to obtain a certain number of additional branches formed by the partial folding of the wire on itself.
Selon l'invention, la portion de raccordement de l'agrafe éduquée de telle sorte à se racourcir sous l'effet de la température, adoptant une forme au moins partiellement recourbée lors du passage à une température supérieure à la température de transformation austénitique du matériau martensitique qui la constitue, est également constituée par le repliage partiel du fil constitutif de l'agrafe, dans le prolongement de la ou des branches latérales ainsi constituées.According to the invention, the connection portion of the clip educated so as to shorten under the effect of temperature, adopting an at least partially curved shape when passing to a temperature above the austenitic transformation temperature of the material martensitic which constitutes it, is also constituted by the partial folding of the wire constituting the staple, in the extension of the lateral branch (es) thus formed.
Selon une autre caractéristique de l'invention, la ou les branches latérales constituées par repliage partiel du fil constitutif sur lui-même, sont susceptibles d'adopter une forme recourbée sous l'effet de la température. De la sorte, on améliore les capacités d'auto-rétention de l'agrafe.According to another characteristic of the invention, the lateral branch or branches formed by partial folding of the constituent wire on itself, are capable of adopting a curved shape under the effect of the temperature. In this way, the self-retaining capabilities of the clip are improved.
Selon une autre caractéristique de l'invention, le raccourcissement de la portion de raccordement de l'agrafe sous l'effet de la température est obtenu par rabat partiel en direction du milieu de ladite agrafe des éléments de la portion constitués par le fil seul et non par repliage partiel de celui-ci sur lui-même.According to another characteristic of the invention, the shortening of the connection portion of the clip under the effect of temperature is obtained by partial flap in the direction of the middle of said clip of the elements of the portion constituted by the wire alone and not by partial folding of the latter on itself.
Selon une autre caractéristique de l'invention, le raccourcissement de la portion de raccordement de l'agrafe sous l'effet de la température est obtenu sous l'effet combiné de l'adoption d'une forme recourbée de la zone de ladite portion constituée par repliage partiel du fil constitutif, et par le rabat en direction du milieu de l'agrafe des éléments de la portion constitués par le fil seul.According to another characteristic of the invention, the shortening of the connection portion of the clip under the effect of temperature is obtained under the combined effect of the adoption of a curved shape in the area of said portion formed by partial folding of the constituent wire, and by the flap towards the middle of the staple of the elements of the portion constituted by the wire alone.
Selon une première forme de réalisation de l'invention, l'agrafe en forme de Y comporte trois branches, dont l'une est constituée par repliage partiel du fil constitutif de l'agrafe sur lui-même, les deux autres branches étant susceptibles de se rapprocher ou de s'écarter l'une de l'autre lors du passage à une température supérieure à la température de transformation austénitique du matériau.According to a first embodiment of the invention, the Y-shaped clip has three branches, one of which is formed by partial folding of the wire constituting the clip on itself, the other two branches being capable of approach or move away from each other when passing at a temperature higher than the austenitic transformation temperature of the material.
Dans une autre forme de réalisation dans laquelle l'agrafe comporte également trois branches, celles-ci sont réparties de telle sorte à conférer à l'agrafe une forme en T, à savoir une branche principale constituée par repliage partiel et les deux autres branches situées à l'extrémité de la barre supérieure du T étant constituées par les deux extrémités libres.In another embodiment in which the clip also has three branches, these are distributed so as to give the clip a T-shape, namely a main branch formed by partial folding and the other two branches located at the end of the upper bar of the T being constituted by the two free ends.
Dans une autre forme de réalisation dans laquelle l'agrafe comporte également trois branches, celles-ci sont réparties de telle sorte à conférer à l'agrafe une forme en V, dans laquelle l'une des branches est constituée par repliage partiel sur lui-même du fil constitutif de l'agrafe, et dans laquelle les deux autres branches sont susceptibles de se rapprocher ou de s'écarter l'une de l'autre lors du passage à une température supérieure à la température de transformation austénitique du matériau.In another embodiment in which the clip also has three branches, these are distributed so as to give the clip a V-shape, in which one of the branches is formed by partial folding over it- even of the constituent wire of the staple, and in which the two other branches are likely to approach or move away from one another when passing at a temperature higher than the austenitic transformation temperature of the material.
Dans une autre forme de réalisation dans laquelle l'agrafe comporte également trois branches, celles-ci sont réparties de telle sorte à conférer à l'agrafe une forme en tabouret, dans laquelle chacune des branches est constituée par repliage partiel du fil constitutif de l'agrafe sur lui-même.In another embodiment in which the clip also has three branches, these are distributed so as to give the clip a stool shape, in which each of the branches is constituted by partial folding of the constituent wire of the clip on itself.
Dans une autre forme de réalisation, l'agrafe comporte quatre branches, réparties de telle sorte à conférer à l'agrafe une forme en double Y, la barre centrale étant commune aux deux Y, les deux branches de l'un d'entre eux étant constituées par repliage partiel sur lui-même du fil, et les deux branches de l'autre étant constituées par les deux extrémités libres dudit fil, les deux branches de chacun des deux jeux étant également susceptibles de se rapprocher ou de s'écarter, en fonction de l'éducation en mémoire de forme qui leur est donnée, lors du passage de la température à une température supérieure à la température de transformation austénitique du matériau.In another embodiment, the clip has four branches, distributed so as to give the clip a double Y shape, the central bar being common to the two Y, the two branches of one of them being formed by partial folding in on itself of the wire, and the two branches of the other being constituted by the two free ends of said wire, the two branches of each of the two sets also being capable of approaching or deviating, according to the education in shape memory which is given to them, at the time of the passage from the temperature to a temperature higher than the austenitic transformation temperature of the material.
Dans une autre forme de réalisation à quatre branches, l'agrafe présente une forme en double T, reliés l'un à l'autre par leur barre principale, deux des branches étant réalisées par repliage partiel sur lui-même du fil, les deux autres étant constituées par les deux extrémités libres dudit fil.In another embodiment with four branches, the clip has a double-T shape, connected to each other by their main bar, two of the branches being produced by partial folding of the wire on itself, both others being constituted by the two free ends of said wire.
Dans une autre forme de réalisation également à quatre branches, l'agrafe présente une forme en tabouret, chacune des branches dudit tabouret étant constituée par le repliage partiel du fil sur lui-même, les deux extrémités libres du fil venant se rejoindre au niveau de l'une des branches. Selon l'éducation donnée à l'agrafe, les différentes portions de raccordement des branches entre elles adoptent une forme ondulée lors du passage de la température à une température supérieure à la température de transformation austénitique du matérieu, ou seules deux portions de raccordement opposées subissent un tel raccourcissement.In another embodiment also with four branches, the clip has a stool shape, each of the branches of said stool being constituted by the partial folding of the wire on itself, the two free ends of the wire coming to meet at one of the branches. According to the education given to the clip, the different connecting portions of the branches between them adopt a wavy shape when the temperature passes to a temperature higher than the austenitic transformation temperature of the material, or only two opposite connecting portions undergo such a shortening.
La manière dont l'invention peut être réalisée et les avantages qui en découlent, ressortiront mieux des exemples de réalisation qui suivent donnés à titre indicatif mais non limitatif, à l'appui des figures annexées.The manner in which the invention can be implemented and the advantages which ensue therefrom will emerge more clearly from the following exemplary embodiments given by way of indication but not limitation, in support of the appended figures.
Les figures 1 et 2a, 2b et 2c représentent une première forme de réalisation de l'invention à trois branches en forme de Y, respectivement à une température inférieure à la température de transformation martensitique et supérieure à la température de transformation austénitique du matériau qui la compose.Figures 1 and 2a, 2b and 2c show a first embodiment of the invention with three Y-shaped branches, respectively at a temperature below the martensitic transformation temperature and above the austenitic transformation temperature of the material which compound.
Les figures 3 et 4a, 4b sont des représentations schématiques de l'agrafe en forme de Y des figures 1 et 2 en place au niveau d'une zone de fracture osseuse.Figures 3 and 4a, 4b are schematic representations of the Y-shaped clip of Figures 1 and 2 in place at a bone fracture area.
Les figures 5 et 6 sont des représentations similaires aux figures 1 et 2, d'une agrafe à trois branches en forme de T.Figures 5 and 6 are representations similar to Figures 1 and 2, of a staple with three T-shaped branches.
La figure 7 est une représentation schématique de la mise en place de l'agrafe des figures 5 et 6 au niveau d'un foyer de fracture osseuse.Figure 7 is a schematic representation of the implementation of the clip of Figures 5 and 6 at a bone fracture focus.
Les figures 8 et 9a, 9b et 9c sont des représentations similaires aux figures 1 et 2, d'une agrafe à quatre branches en forme de double Y.Figures 8 and 9a, 9b and 9c are representations similar to Figures 1 and 2, of a staple with four branches in the form of double Y.
Les figures 10 et 11 sont des représentations similaires aux figures 1 et 2, d'une agrafe à quatre branches en forme de double T.Figures 10 and 11 are representations similar to Figures 1 and 2, of a staple with four branches in the form of double T.
Les figures 12 et 13 sont des figures analogues à celles des figures 10 et 11 d'une agrafe également en forme de double T, selon ne autre forme de réalisation de l'invention.Figures 12 and 13 are figures similar to those of Figures 10 and 11 of a clip also in the form of a double T, according to another embodiment of the invention.
La figure 14 est une représentation schématique de la mise en place de l'agrafe des figures 12 et 13 au niveau d'un foyer de fracture osseuse.Figure 14 is a schematic representation of the placement of the clip of Figures 12 and 13 at a bone fracture focus.
Les figures 15 et 16 sont des représentations similaires aux figures 1 et 2, d'une agrafe à trois branches en forme de V.Figures 15 and 16 are representations similar to Figures 1 and 2, of a staple with three V-shaped branches.
Les figures 17 et 18 sont des représentations schématiques similaires à celles des figures 1 et 2 d'une agrafe à trois branches en forme de tabouret.Figures 17 and 18 are schematic representations similar to those of Figures 1 and 2 of a staple with three branches in the form of a stool.
Les figures 19, 20 et 21 sont des représentations schématiques similaires aux figures 1 et 2 d'une agrafe à quatre branches en forme de tabouret, la figure 21 étant une variante de la figure 20.FIGS. 19, 20 and 21 are schematic representations similar to FIGS. 1 and 2 of a staple with four branches in the form of a stool, FIG. 21 being a variant of FIG. 20.
Les agrafes d'ostéosynthèse selon l'invention sont réalisées en un matériau martensitique répondant aux propriétés de bio-compatibilité requises. Typiquement, ce matériau martensitique est constitué par un alliage en nickel/titane ou en un alliage à base de cuivre, d'aluminium ou de zinc.The osteosynthesis clips according to the invention are made of a martensitic material that meets the required bio-compatibility properties. Typically, this martensitic material consists of a nickel / titanium alloy or an alloy based on copper, aluminum or zinc.
L'agrafe d'ostéosynthèse (1) selon l'invention comprend fondamentalement des branches latérales (2, 3, 4), reliées entre elles par une base ou portion de raccordement (5, 6, 7, 8), l'ensemble de ces différents éléments étant constitué au moyen d'un seul fil monobloc de section circulaire ou polygonale (carré, rectangulaire), etc., réalisé dans ledit alliage.The osteosynthesis clip (1) according to the invention basically comprises lateral branches (2, 3, 4), interconnected by a base or connection portion (5, 6, 7, 8), the set of these various elements being constituted by means of a single monobloc wire of circular or polygonal section (square, rectangular), etc., produced in said alloy.
A la température en dessous de Ms, les branches latérales (2, 3 et 4) décrites plus en détail ci-après, sont rectilignes et dirigées sensi-blement perpendiculairement par rapport à la portion de raccordement.At the temperature below M s , the lateral branches (2, 3 and 4) described in more detail below, are rectilinear and directed appreciably perpendicularly to the connection portion.
Dans une première forme de réalisation décrite notamment en liaison avec les figures 1 à 4b, l'agrafe comporte trois branches latérales (2,3 et 4) et la portion de raccordement forme un Y, dont la base (7, 8) est constituée par repliage partiel du fil constitutif de l'agrafe sur lui-même, et qui se poursuit par deux branches divergentes (5, 6), constituées par le fil de manière unitaire, et dont les deux extrémités libres formes deux des branches latérales (3, 4). L'agrafe est ainsi constituée d'un seul fil monobloc, replié sur lui-même, la branche extrême (2) étant constituée par le repliage partiel du fil sur lui-même, et se poursuivant par la base du Y. Le fil est éduqué de telle sorte que lorsque la température est inférieure à la température martensitique Ms du matériau qui le compose, les branches latérales (2, 3, 4) sont rectilignes, ainsi que les éléments (5, 6, 7, 8) constituant la portion de raccordement dudit Y et, lorsque la température est supérieure à la température de transformation austénitique As dudit matériau, les branches latérales adoptent une position recourbée dirigée vers l'intérieur de l'agrafe, tel que représenté sur la figure 2a, et en outre, la portion de raccordement (7,8) adopte également un profil ondulé ou courbe, par exemple situé dans le plan de la dite portion, de telle sorte à obtenir un raccourcissement de la longueur initiale L de ladite agrafe selon une nouvelle valeur L' (L' < L) (voir figure 2a).In a first embodiment described in particular in connection with FIGS. 1 to 4b, the clip has three lateral branches (2, 3 and 4) and the connection portion forms a Y, the base (7, 8) of which is made up by partial folding of the wire constituting the clip on itself, and which continues with two divergent branches (5, 6), formed by the wire in a unitary manner, and the two free ends of which form two lateral branches (3 , 4). The clip is thus made up of a single monobloc wire, folded back on itself, the extreme branch (2) being constituted by the partial folding of the wire back on itself, and continuing at the base of the Y. The wire is educated so that when the temperature is lower than the martensitic temperature M s of the material of which it is composed, the lateral branches (2, 3, 4) are rectilinear, as well as the elements (5, 6, 7, 8) constituting the connection portion of said Y and, when the temperature is higher than the austenitic transformation temperature A s of said material, the lateral branches adopt a curved position directed towards the inside of the clip, as shown in FIG. 2a, and in addition, the connection portion (7,8) also adopts a corrugated or curved profile, for example located in the plane of said portion, so as to obtain a shortening of the initial length L of said clip according to a new value L '(L'<L) (see FIG. 2a).
Cette mémoire de forme peut être acquise par les différents éléments, à savoir les branches latérales (2, 3, 4) et la portion de raccordement (7, 8) en leur donnant une forme particulière à une température supérieure à la température de transformation austénitique As du matériau qui les compose, puis en leur donnant une autre forme et notamment une forme rectiligne à une température inférieure à la température de transformation martensitique Ms dudit matériau. En répétant un certain nombre de fois cette transformation mécanique, une mémoire de forme rectiligne est acquise respectivement pour la portion de raccordement et pour les branches latérales à une température inférieure à la température de transformation martensitique et une mémoire de forme ondulée ou courbée pour la portion de raccordement (7, 8), avec les branches latérales (2, 3, 4) adoptant une forme recourbée pour une température supérieure au seuil austénitique, sont obtenues.This shape memory can be acquired by the various elements, namely the lateral branches (2, 3, 4) and the connection portion (7, 8) by giving them a particular shape at a temperature higher than the austenitic transformation temperature. A s of the material that composes them, then giving them another shape and in particular a rectilinear shape at a temperature below the martensitic transformation temperature M s of said material. By repeating this mechanical transformation a certain number of times, a rectilinear shape memory is acquired respectively for the connection portion and for the lateral branches at a temperature below the martensitic transformation temperature and a wavy or curved shape memory for the portion connection (7, 8), with the lateral branches (2, 3, 4) adopting a curved shape for a temperature above the austenitic threshold, are obtained.
Dans une variante de l'invention, l'écartement l entre les deux branches supérieures (5, 6) constitutives du Y de la portion de raccordement, et partant entre les branches latérales (2, 3), peut être soit réduit, soit augmenté lorsque la température dépasse le seuil austénitique As du matériau, et ce en fonction de l'effet désiré.In a variant of the invention, the spacing l between the two upper branches (5, 6) constituting the Y of the connection portion, and therefore between the lateral branches (2, 3), can be either reduced or increased when the temperature exceeds the austenitic threshold A s of the material, and this as a function of the desired effect.
De la sorte, il résulte lors de la mise en place de l'agrafe au niveau du patient, induisant donc un passage de la température à une température supérieure à la température de transformation austénitique As du matériau, un raccourcissement de la portion de raccordement (7, 8) de l'agrafe (1), et partant un effet de compression dynamique, et parallèlement un recourbement des branches latérales (2, 3, 4) qui la constituent, pouvant également s'accompagner soit d'un écartement des branches (3,4), soit au contraire un rapprochement de celles-ci.In this way, it results during the positioning of the clip at the level of the patient, thus inducing a passage from the temperature to a temperature higher than the austenitic transformation temperature A s of the material, a shortening of the connection portion. (7, 8) of the clip (1), and therefore a dynamic compression effect, and at the same time a bending of the lateral branches (2, 3, 4) which constitute it, which can also be accompanied by either a separation of the branches (3,4), or on the contrary a bringing together of these.
La mise en place de cette agrafe au niveau de la fracture s'effectue de la manière suivante. La dite agrafe est portée à une température inférieure à la température de transformation martensitique Ms du matériau qui la compose, la portion de raccordement (7,8) et les branches latérales étant de fait rectilignes, ces dernières étant même sensiblement perpendiculaires à ladite portion. L'agrafe est alors implantée de part et d'autre du foyer de la fracture, et ce par compaction, des pré-orifices ayant avantageusement été réalisés préalablement par le chirurgien. Lorsque la température est supérieure au seuil austénitique, l'agrafe se déforme et adopte une forme définie par sa mémoire de forme. De la sorte, on aboutit à un double effet de compression, respectivement au niveau de l'os cortical et de l'os spongieux, ainsi qu'à un effet d'auto-rétention, inhérent au recourbement des branches latérales (2, 3, 4).The placement of this clip at the fracture is carried out as follows. Said clip is brought to a temperature below the martensitic transformation temperature M s of the material of which it is composed, the connection portion (7,8) and the lateral branches being in fact rectilinear, the latter being even substantially perpendicular to said portion. . The clip is then implanted on either side of the focal point of the fracture, and this by compaction, pre-orifices having advantageously been made beforehand by the surgeon. When the temperature is above the austenitic threshold, the clip deforms and adopts a shape defined by its shape memory. In this way, there is a double compression effect, respectively at the level of the cortical bone and the cancellous bone, as well as a self-retention effect, inherent in the bending of the lateral branches (2, 3 , 4).
On a représenté dans les figures 3 et 4, l'agrafe en place au niveau du foyer d'une fracture osseuse, dont on a matérialisé par une ligne brisée la zone de fracture. Selon un premier mode de mise en place (figure 3 et 4a), seule l'une des parois corticales de l'os est percée pour permettre le positionnement de l'agrafe. Selon un autre mode de mise en place (figure 4b), les deux parois corticales opposées de l'os sont percées, de telle sorte à permettre la traversée des branches latérales (2, 3, 4) de part en part de l'os, et partant, d'assurer une meilleure compression des deux éléments de l'os au contact l'un de l'autre, et une stabilité accrue.FIGS. 3 and 4 show the clip in place at the focal point of a bone fracture, of which the broken zone has been shown by a broken line. According to a first method of positioning (FIGS. 3 and 4a), only one of the cortical walls of the bone is pierced to allow the positioning of the staple. According to another method of positioning (FIG. 4b), the two opposite cortical walls of the bone are pierced, so as to allow the lateral branches (2, 3, 4) to pass right through. the bone, and therefore, ensure better compression of the two elements of the bone in contact with each other, and increased stability.
Dans une variante de l'agrafe précédente, représentée sur la figure 2b, le raccourcissement de la portion de raccordement est obtenu par rabat des branches supérieures (5, 6) de ladite portion en direction de la branche latérale (2), obtenu également par mémoire de forme à une température supérieure au seuil austénitique.In a variant of the previous clip, shown in FIG. 2b, the shortening of the connection portion is obtained by flap of the upper branches (5, 6) of said portion in the direction of the lateral branch (2), also obtained by shape memory at a temperature above the austenitic threshold.
Dans une variante des deux formes précédentes représentée sur la figure 2c, le raccourcissement de la portion de raccordement est obtenu par une combinaison des deux effets précédents, à savoir, à la fois par l'adoption par la base (7, 8) de ladite portion d'un profil courbe, et par le repliage ou rabat en direction de la branche latérale (2) des branches supérieures (5, 6) de cette portion.In a variant of the two preceding forms shown in FIG. 2c, the shortening of the connection portion is obtained by a combination of the two preceding effects, namely, both by the adoption by the base (7, 8) of said portion of a curved profile, and by folding or flap towards the lateral branch (2) of the upper branches (5, 6) of this portion.
Dans une autre forme de réalisation de l'invention représentée sur les figures 5 et 6, l'agrafe comporte toujours trois branches latérales (2, 3, 4), mais la portion de raccordement entre ces branches présente une forme en T. Comme dans le cas précédent, l'une des branches (2) est constituée par le repliage partiel sur lui-même du fil qui la constitue, et la portion de raccordement (7, 8) est susceptible de se raccourcir par adoption d'un profil ondulé ou courbe lors du passage de la température au dessus du seuil austénitique. En outre, à une telle température, les deux branches supérieures (5, 6) constitutives de la portion de raccordement, et partant les deux branches latérales (3, 4) qui les prolongent, sont avantageusement éduquées pour se rapporcher l'une de l'autre, tel que matérialisé par les deux flèches sur la figure 6. En outre, les deux branches latérales (3, 4) se recourbent en direction l'une de l'autre à une telle température. De la sorte, et ainsi que cela a été représenté sur la figure 7, une telle agrafe est adaptée pour assurer d'une part, une compression au niveau d'un foyer de fracture osseuse, mais également un second effet de compression, au niveau d'une zone de fêlure (14) contigue à la fracture proprement dite, et ce en assurant un serrage effectif inhérent au rapprochement des deux branches supérieures (5, 6) de la portion de raccordement.In another embodiment of the invention shown in FIGS. 5 and 6, the clip always has three lateral branches (2, 3, 4), but the connection portion between these branches has a T-shape. As in in the previous case, one of the branches (2) is formed by the partial folding in on itself of the wire which constitutes it, and the connection portion (7, 8) is likely to be shortened by adopting a corrugated profile or curve when the temperature goes above the austenitic threshold. In addition, at such a temperature, the two upper branches (5, 6) constituting the connection portion, and hence the two lateral branches (3, 4) which extend them, are advantageously educated to approach one of the 'other, as materialized by the two arrows in Figure 6. In addition, the two side branches (3, 4) bend in the direction of one another at such a temperature. In this way, and as has been shown in Figure 7, such a clip is adapted to ensure on the one hand, compression at a focal point of bone fracture, but also a second compression effect, at the level of a cracked area (14) contiguous to the fracture proper, and this by ensuring an effective tightening inherent in the bringing together of the two upper branches (5, 6) of the connecting portion.
Dans une variante de la forme de réalisation précédente, les deux branches supérieures (5, 6) demeurent sensiblement parallèles et les branches latérales (3, 4) qui les prolongent sont susceptibles d'être introduites dans l'os à consolider, soit au niveau de deux orifices préalablement réalisés par le praticien, et ce de manière plus ou moins rapproché, soit au niveau d'un même orifice, en fonction de la dimension de l'os et de la pathologie rencontrée. Le passage de la température au dessus de la température de tranformation austénitique du matériau induit alors :
- le raccourcissement de l'agrafe, de par l'adoption par la portion de raccordement d'un profil ondulé ou en forme de boucle, et partant générant un effet de compression,
- le rapprochement des extrémités des branches latérales (3, 4), ou leur éloignement, et ce soit dans le plan général de l'agrafe, soit dans un plan perpendiculaire à ladite agrafe, soit encore, le déplacement desdites extrémités selon une même direction, et ce, en direction de la branche (2), ou au contraire dans la direction opposée à cette branche (2).
- the shortening of the clip, by the adoption by the connection portion of a wavy or loop-shaped profile, and therefore generating a compression effect,
- bringing the ends of the lateral branches (3, 4) closer together, or moving them apart, either in the general plane of the staple, or in a plane perpendicular to said staple, or again, the displacement of said ends in the same direction, and this, in the direction of the branch (2), or on the contrary in the direction opposite to this branch (2).
Dans une autre forme de réalisation représentée dans les figures 8 et 9, l'agrafe présente quatre branches latérales (2, 3, 4, 9) selon une forme générale de deux Y bout à bout. Deux des branches latérales (2, 9) sont constituées par repliage partiel du fil sur lui-même, et les deux autres sont constituées par les deux extrémités libres dudit fil. Ainsi qu'on peut l'observer, la portion de raccordement est constituée d'une part, par le prolongement des branches latérales (2, 9), et donc par repliage partiel sur lui-même du fil constitutif de l'agrafe, et d'autre part, par les branches supérieures (5, 6) divergeant à partir de la zone centrale de l'agrafe, et dont les extrémités libres constituent les deux branches latérales (3, 4). Comme dans le cas précédent, la portion de raccordement "double" (7, 8) est susceptible de subir une déformation par mémoire de forme selon une double ondulation ou courbure, avantageusement dans le plan de ladite portion, se matérialisant par un raccourcissement de l'agrafe (1). En outre, ce raccourcissement peut également être obtenu par rabat ou repliage partiel des branches supérieures (5, 6) de la portion de raccordement en direction des branches latérales (2, 9) (voir figure 9b), ou encore par combinaison des deux effets précédents (voir figure 9c).In another embodiment shown in Figures 8 and 9, the clip has four side branches (2, 3, 4, 9) in a general shape of two Y end to end. Two of the side branches (2, 9) are formed by partial folding of the wire on itself, and the other two are formed by the two free ends of said wire. As can be observed, the connection portion is made up on the one hand, by the extension of the lateral branches (2, 9), and therefore by partial folding back on itself of the wire constituting the staple, and on the other hand, by the branches upper (5, 6) diverging from the central area of the clip, and whose free ends constitute the two lateral branches (3, 4). As in the previous case, the "double" connection portion (7, 8) is liable to undergo deformation by shape memory according to a double undulation or curvature, advantageously in the plane of said portion, materializing by a shortening of the 'clip (1). In addition, this shortening can also be obtained by flap or partial folding of the upper branches (5, 6) of the connection portion in the direction of the lateral branches (2, 9) (see FIG. 9b), or by combination of the two effects. previous (see Figure 9c).
Parallèlement, les deux branches latérales, respectivement (3, 4) et (2, 9) constitutives des deux jeux de branches du double Y, sont susceptibles de s'écarter ou au contraire de se rapprocher l'une de l'autre lors du passage de la température au dessus du seuil de transformation austénitique du matériau, voire l'un des jeux s'écarter et l'autre se rapprocher en fonction de l'effet désiré. Cet effet est obtenu par éducation, à l'instar des effets précédemment décrits.In parallel, the two lateral branches, respectively (3, 4) and (2, 9) constituting the two sets of branches of the double Y, are liable to deviate or, on the contrary, to approach one another during the passage of the temperature above the austenitic transformation threshold of the material, or even one of the clearances deviate and the other approximate depending on the desired effect. This effect is obtained by education, like the effects previously described.
Dans une forme de réalisation représentée sur les figures 10 et 11, l'agrafe comporte quatre branches latérales (2, 3, 4, 9), raccordées entre elles par un portion de raccordement en forme de double T, comprenant respectivement deux branches latérales (2, 9) réalisées par repliage partiel sur lui-même du fil constitutif de l'agrafe, et deux branches latérales (3, 4) constituées par les deux extrémités libres dudit fil. A une température supérieure à la température de transformation austéniti-que As du matériau, on observe sur la figure 11, l'adoption par la portion de raccordement "double" (7, 8) d'un profil ondulé ou courbe, propre à induire une diminution de la distance séparant les deux jeux de deux branches latérales, et partant à assurer la compression dynamique au niveau de la fracture. Par ailleurs, lesdites branches latérales de chacun des deux jeux, respectivement (2, 9) et (3, 4) sont éduquées de telle sorte qu'à une telle température, elles se recourbent en direction du jeu de branches latérales opposé.In an embodiment shown in FIGS. 10 and 11, the clip has four lateral branches (2, 3, 4, 9), connected together by a double T-shaped connecting portion, comprising respectively two lateral branches ( 2, 9) produced by partial folding in on itself of the wire constituting the staple, and two lateral branches (3, 4) constituted by the two free ends of said wire. At a temperature higher than the austenitic transformation temperature A s of the material, we observe in FIG. 11, the adoption by the "double" connection portion (7, 8) of a wavy or curved profile, suitable for induce a reduction in the distance separating the two sets of two lateral branches, and thereby ensuring dynamic compression at fracture level. Furthermore, said side branches of each of the two sets, respectively (2, 9) and (3, 4) are educated so that at such a temperature, they bend in the direction of the set of opposite side branches.
Dans une variante de la forme de réalisation précédente, représentée sur les figures 12 et 13, les branches latérales (2, 3, 4, 9) sont éduquées pour se présenter sous une forme légèrement cintrée à une température inférieure à la température de transformation martensitique Ms du matériau, et pour adopter une forme beaucoup plus cintrée (figure 13) à une température supérieure au seuil austénitique. Ce cintrage s'effectue sensiblement dans le plan intégrant les deux jeux respectifs (2, 9) et (3, 4) de branches latérales. Cette forme de réalisation de l'invention s'avère d'application avantageuse pour la réduction de fracture ou de fêlure d'os de petite taille. En effet, et tel qu'on l'a schématiquement représenté sur la figure 14, les branches latérales ne pénètrent plus dans l'os, mais l'entourent, et assurent un serrage et une compression dynamique propre à permettre sa "réparation", les dimensions de l'agrafe, et notamment le degré de cintrage des branches latérales étant choisis de telle sorte à assurer le degré de serrage voulu.In a variant of the previous embodiment, shown in Figures 12 and 13, the lateral branches (2, 3, 4, 9) are educated to be in a slightly bent form at a temperature below the martensitic transformation temperature M s of the material, and to adopt a much more curved shape (FIG. 13) at a temperature above the austenitic threshold. This bending takes place substantially in the plane integrating the two respective sets (2, 9) and (3, 4) of lateral branches. This embodiment of the invention proves to be of advantageous application for the reduction of fractures or fractures of small bones. Indeed, and as schematically shown in FIG. 14, the lateral branches no longer penetrate into the bone, but surround it, and provide a tightening and a dynamic compression capable of allowing its "repair", the dimensions of the clip, and in particular the degree of bending of the lateral branches being chosen so as to ensure the desired degree of tightening.
Dans une autre forme de réalisation de l'invention, dans laquelle l'agrafe comporte trois branches latérales, représentée sur les figures 15 et 16, la portion de raccordement est en forme de V. Comme dans les exemples précédents, ladite portion (7, 8) est éduquée pour se raccourcir en adoptant un profil courbe ou ondulé dès lors que la température dépasse le seuil austénitique, et chacune des branches latérales (2, 3, 4) se recourbe en direction du centre de l'agrafe à une telle température.In another embodiment of the invention, in which the clip comprises three lateral branches, shown in FIGS. 15 and 16, the connection portion is in the form of a V. As in the previous examples, said portion (7, 8) is educated to shorten by adopting a curved or wavy profile as soon as the temperature exceeds the austenitic threshold, and each of the lateral branches (2, 3, 4) bends towards the center of the clip at such a temperature .
Dans une autre forme de réalisation de l'invention représentée sur les figures 17 et 18, l'agrafe comporte également trois branches latérales (2, 3, 4), mais selon une forme en tabouret. Les trois branches sont alors chacune constituée par repliage partiel sur lui-même du fil constitutif de l'agrafe, et sont éduquées pour se recourber en direction du centre de l'agrafe à une température supérieure au seuil austénitique du matériau. Parallèlement, à une telle température, les portions de raccordement entre lesdites branches sont éduquées pour adopter un profil cintré, de telle sorte à réduire la distance séparant lesdites branches latérales. De fait, ce type d'agrafe est d'application pour la réduction des fractures osseuses multiples, du type métacarpien.In another embodiment of the invention shown in Figures 17 and 18, the clip also has three lateral branches (2, 3, 4), but in a stool shape. The three branches are then each formed by partial folding in on itself of the wire constituting the staple, and are educated to curl in the direction of the center of the staple at a temperature above the austenitic threshold of the material. At the same time, at such a temperature, the connecting portions between said branches are educated to adopt a curved profile, so as to reduce the distance separating said lateral branches. In fact, this type of staple is applicable for the reduction of multiple bone fractures, of the metacarpal type.
Dans le même esprit, on a représenté sur les figures 19, 20 et 21 une agrafe en forme de tabouret, mais comportant quatre branches latérales régulièrement réparties. Dans la réalisation décrite, chacune des branches est constituée par un repliage partiel du fil, les deux extrémités libres du fil se rejoignant par exemple au niveau de l'une des branches. Lors du passage au dessus du seuil austénitique As du matériau, les différentes portions de raccordement (10 - 13) subissent une modification de forme selon une forme ondulée ou cintrée, induisant un raccourcissement de chacune des diagonales constituant la base du tabouret.In the same spirit, there is shown in Figures 19, 20 and 21 a staple-shaped clip, but having four regularly distributed side branches. In the embodiment described, each of the branches is constituted by a partial folding of the wire, the two free ends of the wire joining, for example at one of the branches. When passing over the austenitic threshold A s of the material, the different connecting portions (10 - 13) undergo a change in shape according to a wavy or curved shape, inducing a shortening of each of the diagonals constituting the base of the stool.
Dans la forme de réalisation illustrée sur la figure 21, on peut prévoir que seules deux portions de raccordement opposées, par exemple (11, 12) soient éduquées de telle sorte à présenter une forme ondulée, et partant un raccourcissement de la distance séparant les deux couples de branches latérales (2, 4) et (3, 9) lors du passage de la température au dessus du seuil austénitique, et ce en fonction du choix du chirurgien.In the embodiment illustrated in Figure 21, it can be provided that only two opposite connection portions, for example (11, 12) are educated so as to have a wavy shape, and therefore a shortening of the distance separating the two pairs of lateral branches (2, 4) and (3, 9) when the temperature passes above the austenitic threshold, depending on the choice of the surgeon.
On conçoit donc que de par l'adoption d'un fil unitaire monobloc pour la réalisation de ces agrafes multi-branches, de même que leur éducation en vue de leur conférer une mémoire de forme bien spécifique est beaucoup plus aisée. En outre, compte tenu du double effet de compression souhaitée, de leur capacité auto-rétentive et de la stabilité mécanique accrue qu'elles induisent au niveau du foyer de fracture, ces agrafes s'avèrent tout particulièrement adaptées pour la réduction de nombreux types de fractures.It is therefore understandable that, by adopting a single unitary wire for the production of these multi-branch staples, as well as educating them with a view to giving them a very specific shape memory is much easier. In addition, given the desired double compression effect, their self-retentive capacity and the increased mechanical stability which they induce at the fracture site, these staples prove to be particularly suitable for the reduction of many types of fractures.
Claims (15)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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FR9311429 | 1993-09-21 | ||
FR9311429A FR2710254B1 (en) | 1993-09-21 | 1993-09-21 | Multi-branch osteosynthesis clip with self-retaining dynamic compression. |
Publications (2)
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EP0646353A1 true EP0646353A1 (en) | 1995-04-05 |
EP0646353B1 EP0646353B1 (en) | 1997-11-26 |
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EP94420247A Expired - Lifetime EP0646353B1 (en) | 1993-09-21 | 1994-09-15 | Multi-branched ostheosynthesis staple having a dynamic autoretentive compression |
Country Status (5)
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US (1) | US5474557A (en) |
EP (1) | EP0646353B1 (en) |
AT (1) | ATE160492T1 (en) |
DE (1) | DE69407017D1 (en) |
FR (1) | FR2710254B1 (en) |
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AU697490B2 (en) * | 1993-06-04 | 1998-10-08 | Smith & Nephew, Inc. | Surgical staple and washer |
EP0743045A2 (en) * | 1995-04-28 | 1996-11-20 | Gazzani, Romolo Igino | Devices for osteosynthesis |
EP0743045A3 (en) * | 1995-04-28 | 1996-12-27 | Gazzani Romolo Igino | |
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WO1997035528A1 (en) * | 1996-03-26 | 1997-10-02 | Waldemar Link (Gmbh & Co.) | Implant for fixing bone fragments after an osteotomy |
US6203545B1 (en) * | 1996-03-26 | 2001-03-20 | Waldemar Link (Gmbh & Co.) | Implant for fixing bone fragments after an osteotomy |
FR2754702A1 (en) * | 1996-10-18 | 1998-04-24 | Medinov Amp | DEVICE FOR SOLIDARIZING AT LEAST TWO VERTEBRAL BODIES |
WO1998017189A1 (en) * | 1996-10-18 | 1998-04-30 | Depuy France | Device for securing at least two vertebrae |
US6336928B1 (en) | 1996-10-18 | 2002-01-08 | Depuy France | Device for securing at least two vertebrae |
DE10135771A1 (en) * | 2001-07-23 | 2003-02-20 | Aesculap Ag & Co Kg | Vertebral facet joint implant comprises at least one fixing element with surfaces which are in full areal contact with at least one facet |
DE10135771B4 (en) * | 2001-07-23 | 2006-02-16 | Aesculap Ag & Co. Kg | Facet joint implant |
FR3023468A1 (en) * | 2014-07-09 | 2016-01-15 | Euros Sa | ORTHOPEDIC OSTEOSYNTHESIS AGRAFE AND INSTRUMENT FOR THE PLACEMENT OF THIS AGRAFE |
Also Published As
Publication number | Publication date |
---|---|
US5474557A (en) | 1995-12-12 |
ATE160492T1 (en) | 1997-12-15 |
FR2710254B1 (en) | 1995-10-27 |
EP0646353B1 (en) | 1997-11-26 |
FR2710254A1 (en) | 1995-03-31 |
DE69407017D1 (en) | 1998-01-08 |
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